Professionals

Responsible Pharmacist

ESSENTIAL INFORMATION ON THE RESPONSIBLE PHARMACIST REGULATIONS

The Medicines (Pharmacies) (Responsible Pharmacist Regulations 2008 come into force on 1 October 2009, and require every registered pharmacy to:

  • have a "Responsible Pharmacist" to secure the safe and effective running of the pharmacy
  • conspicuously display to the public the name and registration number of the current Responsible Pharmacist
  • maintain a Pharmacy Record detailing who has been the Responsible Pharmacist at any particular time
  • maintain and operate Pharmacy Procedures on a range of specified matters

The regulations also permit a Responsible Pharmacist to be absent from the pharmacy for a maximum of two hours provided statutory conditions are met.

Set out below are some documents and sources of information to assist pharmacists in meeting the new requirements.

The Medicines (Pharmacies) (Responsible Pharmacist Regulations 2008

The Responsible Pharmacist Regulations, passed by Parliament in 2008, set out in short, clear and definitive form the exact legal requirements to be met by pharmacists in relation to the Responsible Pharmacist Regulations, particularly around:

  • The matters to be covered in the Pharmacy Procedures;
  • The particulars to be included in the Pharmacy Record; and,
  • The regulations around the Responsible Pharmacist's absence from the Pharmacy.

The regulations should be read in conjunction with Sections 26 to 33 of the Health Act 2006 which amended the pharmacy supervision requirements of the Medicines Act 1968 and created the obligation of the Responsible Pharmacist. These sections state such matters as what is required by law in relation to display of notice.

Professional Standards and Guidance for Pharmacists in Northern Ireland on the Responsible Pharmacist Regulations 

The Pharmaceutical Society of Northern Ireland, in consultation with the profession and members of the public, has published Professional Standards and Guidance for pharmacists around the Responsible Pharmacist requirements.

As well as reemphasising the legal requirements of the regulations, the Standards and Guidance set out what the professional regulator expects of pharmacists around such areas as review of Procedures, information to be included in the Pharmacy Record, and good practice advice on taking absence. 

Adherence to Professional Standards is expected as a condition of registration with the Pharmaceutical Society of Northern Ireland.

The Department of Health's Guidance on the Responsible Pharmacist regulations

The Department of Health's (London) guidance on the Responsible Pharmacist regulations gives the background, context and purpose of the changes. It also provides detail on such matters as:

  • the definition of the Responsible Pharmacist;
  • how the regulations apply to locum pharmacists;
  • the legal responsibilities of Pharmacy Owners and Superintendents;
  • the purpose of the Pharmacy Record; and,
  • what is meant by absence.

Guidance to Hospital Pharmacists on the Responsible Pharmacist Regulations

The Pharmaceutical Society of Northern Ireland and the Royal Pharmaceutical Society of Great Britain have published joint guidance for hospital pharmacists on implementing the Responsible Pharmacist regulations.

It provides some illustrative scenarios of everday practise issues as well as a Frequently Asked Questions section.

Guidance on pharmacy activities in the Responsible Pharmacist's Absence

The Pharmaceutical Society of Northern Ireland fed into, and supports, an important piece of Guidance developed by the Royal Pharmaceutical Society of Great Britain which describes relevant pharmacy activities and whether they:

  1. Require a Responsible Pharmacist to be in charge of the premises (s/he may be absent for up to two hours per day) and will need to take place under the supervision of a pharmacist and who will need to be present at the premises
  2. Require a Responsible Pharmacist to be in charge of the premises (s/he may be absent for up to two hours per day) and take place under the supervision of a pharmacist who may not need to be physically present at the premises
  3. Require a Responsible Pharmacist to be in charge of the premises (s/he may be absent for up to two hours) but does not require the supervision of a pharmacist; or
  4. Do not require a Responsible Pharmacist to be in charge of the premises but does require the pharmacy support staff undertaking the activity to be appropriately trained and for the activity to be conducted under standard operating procedures.

Template Responsible Pharmacist Notices

To assist pharmacists in the application of the new regulations, the Pharmaceutical Society of Northern Ireland has provided some simple template notices that can be adjusted as required with your pharmacy's logo or other branding.

Once tailored and produced to your pharmacy's requirements, the notices could, for example, be laminated and completed with marker or felt-tip pen.

It is essential however that the notice is "conspicously displayed" as required in Section 27 (3) of the Health Act 2006

A range of other useful tools, such as FAQs and example Procedures, are available on the NPA and Chemist and Druggist website: http://www.chemistanddruggist.co.uk/responsiblepharmacist/

Further advice on the application of the Responsible Pharmacist Regulations can be obtained by contacting Society House.

Contact details

73 University Street, Belfast BT7 1HL
Tel 028 9032 6927
Email info@psni.org.uk